SAFETY DATA SHEET Issuing date 13-Jun-2012 Revision Date 13-Jun-2012 Version 001 SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1 Product identifier Product name HibiClens 1.2 Relevant identified uses of the substance or mixture and uses advised against Recommended Use Uses advised against Antimicrobial agent 1.3 Details of the supplier of the safety data sheet Company Information Mölnlycke Health Care 2 Omega Drive Irlam M44 5BJ United Kingdom Telephone +44 (0) 161 777 2600 Fax +44 (0) 161 777 2601 For further information, please contact: E-mail Address Antiseptics.UK@molnlycke.com 1.4 Emergency telephone Emergency telephone +44 (0) 161 621 2121 (9am-5pm) SECTION 2: Hazards identification 2.1 Classification of the substance or mixture Classification according to EU Directives 67/548/EEC or 1999/45/EC Xi; R36 N; R50/53 2.2 Label elements Xi - Irritant N - Dangerous for the environment R-phrase(s) R36 - Irritating to eyes R50/53 - Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment EN Page 1 / 8
S-phrase(s) S 2 - Keep out of the reach of children S29 - Do not empty into drains S61 - Avoid release to the environment. Refer to special instructions/ Safety data sheets S24/25 - Avoid contact with skin and eyes S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection 2.3 Other hazards May cause skin irritation. May cause irritation of respiratory tract. This preparation contains no substance considered to be very persistent nor very bioaccumulating (vpvb). This substance is not considered to be very persistent nor very bioaccumulating (vpvb). SECTION 3: Composition/information on ingredients 3.2 Mixtures. Chemical Name EC-No CAS-No w/w% Classification (67/548/EEC) Chlorhexidine digluconate 242-354-0 18472-51-0 1-4 Xi; R41 N; R50/53 Isopropyl alcohol 200-661-7 67-63-0 1-4 F; R11 Xi; R36 R67 For the full text of R-phrases and H-Statements see Section 16 Classification (EU Reg. 1272/2008) Eye Dam. 1 (H318) Acute Aquatic 1 (H400) Chronic Aquatic 1 (H410) GHS05, GHS09 (Dgr) Eye Irrit. 2 (H319) STOT SE 3 (H336) Flam. Liq. 2 (H225) GHS02,GHS07 (Dgr) REACH Registration Number no data available no data available SECTION 4: First aid measures 4.1 Description of first aid measures Eye contact Skin contact Ingestion Inhalation Rinse immediately with plenty of water, also under the eyelids, for at least 15 minutes. If symptoms develop obtain medical attention. Wash off immediately with plenty of water. If symptoms develop obtain medical attention. Wash out mouth with water and give 100-200 ml of water to drink. Never give anything by mouth to an unconscious person. Do NOT induce vomiting. If symptoms develop obtain medical attention. Remove to fresh air and keep at a rest position. Administer oxygen if breathing is difficult and you are trained. If symptoms develop obtain medical attention. 4.2 Most important symptoms and effects, both acute and delayed Main Symptoms Irritating to eyes. Prolonged skin contact may cause skin irritation. Inhalation of vapors in high concentration may cause irritation of respiratory system: Headache, dizziness and loss of coordination. 4.3 Indication of any immediate medical attention and special treatment needed Notes to physician Treat symptomatically. EN Page 2 / 8
SECTION 5: Firefighting measures 5.1 Extinguishing media Suitable Extinguishing Media Water spray, Dry chemical, Carbon dioxide (CO 2), Alcohol-resistant foam. Extinguishing media which shall not be used for safety reasons Do not use water jet. 5.2 Special hazards arising from the substance or mixture Combustible material: If overheated, the product may release flammable vapours that can form explosive gas mixtures. Runoff may pollute waterways. Thermal decomposition can lead to release of irritating and toxic gases and vapours: Carbon monoxide (CO). Carbon dioxide (CO 2). Nitrogen oxides (NOx). Ammonia. 5.3 Advice for firefighters As in any fire, wear self-contained breathing apparatus and full protective gear. SECTION 6: Accidental release measures 6.1 Personal precautions, protective equipment and emergency procedures Avoid contact with the skin and the eyes. Avoid breathing vapours or mists. Ensure adequate ventilation. Use personal protective equipment. 6.2 Environmental precautions Avoid release to the environment. Local authorities should be advised if significant spillages cannot be contained. 6.3 Methods and materials for containment and cleaning up Dike to collect large liquid spills. Absorb with earth, sand or other non-combustible material and transfer to containers for later disposal. Use only non-sparking tools. Flush spillage area with plenty of water. 6.4 Reference to other sections See section 8. Waste Disposal Methods: See also section 13. SECTION 7: Handling and storage 7.1 Precautions for safe handling Avoid contact with skin and eyes. Do not breathe vapours or spray mist. Wash thoroughly after handling. Use only in well-ventilated areas. Wear personal protective equipment. Do not eat, drink or smoke when using this product. 7.2 Conditions for safe storage, including any incompatibilities Keep container tightly closed in a dry and well-ventilated place. Keep away from direct sunlight. Store at room temperature. Store separately from incompatible materials: Oxidising agents. Anionic compounds. 7.3 Specific end use(s) Antimicrobial agent. EN Page 3 / 8
SECTION 8: Exposure controls/personal protection 8.1 Control parameters Chemical Name Isopropyl alcohol 67-63-0 The United Kingdom STEL: 500 ppm STEL: 1250 mg/m 3 TWA: 400 ppm TWA: 999 mg/m 3 France VLCT: 400 ppm VLCT: 980 mg/m 3 Spain VLA-EC: 400 ppm VLA-EC: 1000 mg/m 3 Germany VLA-ED: 200 ppm VLA-ED: 500 mg/m 3 TWA: 200 ppm TWA: 500 mg/m 3 Ceiling / Peak: 400 ppm Ceiling / Peak: 1000 mg/m 3 Portugal STEL: 400 ppm TWA: 200 ppm Finland TWA: 200 ppm TWA: 500 mg/m 3 STEL: 250 ppm STEL: 620 mg/m 3 Denmark TWA: 200 ppm TWA: 490 mg/m 3 Austria STEL 800 ppm STEL 2000 mg/m 3 MAK: 200 ppm MAK: 500 mg/m 3 Switzerland STEL: 400 ppm STEL: 1000 mg/m 3 MAK: 200 ppm MAK: 500 mg/m 3 Poland NDSCh: 1200 mg/m 3 NDS: 900 mg/m 3 Skin Norway TWA: 100 ppm TWA: 245 mg/m 3 Ireland STEL: 150 ppm STEL: 306.25 mg/m 3 TWA: 200 ppm STEL: 400 ppm Skin Derived No Effect Level (DNEL). Predicted No Effect Concentration (PNEC). 8.2 Exposure controls Appropriate engineering controls Provide adequate ventilation, including appropriate local extraction, to ensure that occupational exposure limits are not exceeded. Personal protective equipment Eye Protection Safety glasses with side-shields (EN 166). Hand Protection Protective gloves (EN 374). Skin and body protection Wear suitable protective clothing; Protective shoes or boots. Respiratory protection In case of insufficient ventilation wear suitable respiratory equipment; (BS EN 14387:2004+A1). Hygiene measures Handle in accordance with good industrial hygiene and safety practice. Environmental Exposure Controls Avoid release to the environment. The product should not be allowed to enter drains, water courses or the soil. EN Page 4 / 8
SECTION 9: Physical and chemical properties 9.1 Information on basic physical and chemical properties Physical state Liquid Appearance Clear Odour Fragrance Colour Pink Odor Threshold Property Values Remarks Methods ph 5-6.5 Melting/freezing point Freezing Point Boiling point/boiling range Flash Point 64.4 C / 148 F Evaporation rate Flammability (solid, gas) Flammability Limits in Air isopropamol upper flammability limit 12 lower flammability limit 2 Vapour pressure Vapour density Relative density 1.06 Water solubility Miscible Solubility in other solvents Partition coefficient: n-octanol/water Auto-ignition temperature Decomposition temperature Viscosity, kinematic Viscosity, dynamic Explosive properties Oxidizing properties Not explosive Not applicable 9.2 Other information Softening point Molecular Weight VOC Content(%) Density Bulk Density SECTION 10: Stability and reactivity 10.1 Reactivity None known. 10.2 Chemical stability Stable under recommended storage conditions. 10.3 Possibility of hazardous reactions Hazardous polymerization does not occur. 10.4 Conditions to avoid High temperatures. EN Page 5 / 8
10.5 Incompatible materials Oxidizing agents. Anionic compounds. 10.6 Hazardous decomposition products Thermal decomposition can lead to release of irritating and toxic gases and vapours: Carbon monoxide (CO). Carbon dioxide (CO 2). Nitrogen oxides (NOx). Ammonia. SECTION 11: Toxicological information 11.1 Information on toxicological effects Acute toxicity Chemical Name LD50 Oral LD50 Dermal LC50 Inhalation Chlorhexidine digluconate > 2 g/kg ( Rat ) > 5000 mg/kg (Rabbit) Skin corrosion/irritation Serious eye damage/irritation Respiratory or skin sensitisation Mutagenicity Carcinogenicity Repeated or prolonged contact may cause irritation. Irritating to eyes. Not sensitising. Chemical Name European Union IARC Isopropyl alcohol Group 1 Group 3 Reproductive toxicity STOT - Single exposure STOT - Repeated exposure Aspiration hazard Other information. SECTION 12: Ecological information 12.1 Toxicity Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment. Chemical Name Toxicity to algae Toxicity to fish Toxicity to daphnia and other aquatic invertebrates Isopropyl alcohol >1000: 72 h Desmodesmus 11130: 96 h Pimephales promelas 13299: 48 h Daphnia magna mg/l subspicatus mg/l EC50 >1000: 96 mg/l LC50 static 9640: 96 h EC50 h Desmodesmus subspicatus mg/l Pimephales promelas mg/l LC50 EC50 flow-through >1400000: 96 h Lepomis macrochirus µg/l LC50 Chlorhexidine digluconate ErC10: 0.03 mg/l 72 h scenedesmus subspicatus LC50: 2.08 mg/l 96h Brachydanio rerio EC50: 0.087 mg/l 48h Daphnia magna NOEC: 0.0206 mg/l 21d Daphnia magna EN Page 6 / 8
12.2 Persistence and degradability. 12.3 Bioaccumulative potential 12.4 Mobility in soil. 12.5 Results of PBT and vpvb assessment Chemical Name log Pow Isopropyl alcohol 0.05 This preparation contains no substance considered to be persistent, bioaccumulating nor toxic (PBT). This preparation contains no substance considered to be very persistent nor very bioaccumulating (vpvb). 12.6 Other adverse effects Chemical Name Chlorhexidine digluconate Toxicity to microorganisms COD: 219000 mg/i BOD5: 0 mg/i SECTION 13: Disposal considerations 13.1 Waste treatment methods Waste from residues / unused products Contaminated packaging Dispose of in accordance with local regulations. Empty containers should be taken to an approved waste handling site for recycling or disposal. SECTION 14: Transport information ADR/RID/ADN ICAO/IATA IMDG / IMO 14.1 UN Number 3082 3082 3082 14.2 UN proper shipping name ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID, N.O.S. ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID, N.O.S. ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID, N.O.S. 14.3 Transport hazard class(es) 9 9 9 14.4 Packing group III III III 14.5 Environmental Hazards Marine pollutant Marine pollutant Marine pollutant 14.6 Special precautions for user Avoid release to the environment 14.7 Transport in bulk according to MARPOL 73/78 and the IBC Code EN Page 7 / 8
SECTION 15: Regulatory information 15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture Classification according to EU Directives 67/548/EEC or 1999/45/EC. This material safety data sheet complies with the requirements of Regulation (EC) No. 1907/2006. 15.2 Chemical Safety Assessment Chemical Safety Assessment has not been carried out. SECTION 16: Other information Full text of R-phrases referred to under sections 2 and 3 R11 - Highly flammable R36 - Irritating to eyes R41 - Risk of serious damage to eyes R67 - Vapours may cause drowsiness and dizziness R50/53 - Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment Full text of H-Statements referred to under sections 2 and 3 H225 - Highly flammable liquid and vapor H318 - Causes serious eye damage H319 - Causes serious eye irritation H336 - May cause drowsiness or dizziness H400 - Very toxic to aquatic life H410 - Very toxic to aquatic life with long lasting effects Issuing Date 13-Jun-2012 Revision Note This SDS was updated according to regulation (EU) No 453/2010. Disclaimer The information and recommendations contained herein are based upon data believed to be up-to-date and correct. However, no guarantee or warranty of any kind, express or implied, is made with respect to the information and recommendations contained herein. We accept no responsibility and disclaim all liability for any harmful effects that may be caused by (incorrect) use, handling, purchase, resale, or exposure to our product. Customers and users of our product must comply with all applicable health and safety laws, regulations, and orders. In particular, they are under an obligation to carry out a risk assessment for the particular work places and to take adequate risk management measures in accordance with the national implementation legislation of EU Directives 89/391 and 98/24. EN Page 8 / 8